Leukemia Clinical Trial
Official title:
A Phase II Study of Cyclophosphamide Followed by Topotecan in Patients With Refractory or Relapsed Acute Myelogenous Leukemia
Verified date | May 2014 |
Source | Sidney Kimmel Comprehensive Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of cyclophosphamide plus topotecan in
treating patients who have refractory or relapsed acute myelogenous leukemia.
Status | Completed |
Enrollment | 0 |
Est. completion date | February 2000 |
Est. primary completion date | February 2000 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: Histologically proven acute myelogenous leukemia by bone marrow
aspirate or biopsy Clear evidence of relapse or residual disease with greater than 5%
blasts on bone marrow examination or greater than 30% peripheral blasts No active CNS
leukemia Not eligible for potentially curative allogeneic or autologous bone marrow
transplantation without further surgery Must have failed to achieve a complete remission
with conventional chemotherapy (cytarabine based) or have relapsed within 12 months after
initial remission PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 6 weeks Hematopoietic: See Disease Characteristics Hepatic: Bilirubin less than 1.6 mg/dL (unless due to disease) Renal: Creatinine less than 1.6 mg/dL (unless due to disease) No prior hemorrhagic cystitis Other: Not pregnant Fertile patients must use effective contraception No active uncontrolled infection PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics Recovered from prior chemotherapy No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: Must have recovered from prior radiotherapy Surgery: Not specified |
Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins Oncology Center | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Sidney Kimmel Comprehensive Cancer Center | National Cancer Institute (NCI) |
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